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Inovio Pharmaceuticals, Inc. (Nasdaq: INO) announced it has initiated a clinical study of its preventive Zika vaccine (GLS-5700) in 160 subjects in Puerto Rico, where the Zika virus outbreak has been declared a public health emergency. The CDC estimates Zika will infect more than 25% of the Puerto Rican population by year end, providing the potential for this study’s placebo control design to provide exploratory signals of vaccine efficacy.

Dr. J. Joseph Kim, Inovio’s President & CEO, said, “The rapid progression of the Zika outbreak in Puerto Rico provides an immediate and unique opportunity to assess a preventive vaccine in a real world setting. Inovio and its collaborators are moving ahead with this second Zika vaccine clinical trial to evaluate safety, immune responses, and possible signals of vaccine efficacy. If the results are promising, we plan to meet with regulators in 2017 to map out the most efficient path forward to develop our Zika vaccine and help mitigate this widespread Zika outbreak that has expanded into the continental United States.”

Inovio is developing its Zika vaccine, GLS-5700, with GeneOne Life Science, Inc. (KSE: 011000) and academic collaborators from the US and Canada who are also working to advance Inovio’s Ebola and MERS vaccines through clinical development.

In June, Inovio was the first to commence a human Zika trial, with sites in the U.S. and Canada. All 40 subjects for the first clinical study have been fully enrolled and dosed. Inovio expects to report results before the end of this year.

There are no approved vaccines or therapies for Zika virus infection. While multiple companies and academic groups have announced development plans for Zika virus vaccines, only Inovio and a US government research center have started human clinical studies.

Inovio’s second clinical study is a placebo-controlled, double-blind trial involving 160 healthy adult volunteers (80 subjects will receive vaccine and 80 subjects will receive placebo) to evaluate the safety, tolerability and immunogenicity of GLS-5700 administered with Inovio’s CELLECTRA®-3P device. This proprietary intradermal DNA vaccine delivery device has been shown to maximize antigen expression and immune responses in multiple human studies. Inovio will also assess differences in Zika infection rates in participants given either placebo or vaccine as part of an exploratory endpoint. In preclinical testing, this synthetic vaccine induced robust antibody and T cell responses - the immune responses necessary to fight viral infections - in small and large animal models.

About the Zika Virus

First identified in Uganda, Zika virus subsequently spread to equatorial Asia and over the past 10 years has rapidly spread through the South Pacific and into South America, Central America, and the Caribbean. Zika virus is a flavivirus, a family of viruses including yellow fever, dengue, and West Nile virus, which are introduced to people through mosquito bites. Because the Aedes species of mosquitoes that can potentially transmit Zika virus are found throughout the world there is concern that Zika will continue to spread to new countries and regions. As of August, 2016, 66 countries and territories reported evidence of mosquito-borne transmission of the Zika virus since 2015, compared to 33 countries stated by WHO in their first Zika situation report in February 2016. Zika can also be sexually transmitted.

The most common symptoms of Zika virus are fever, rash, joint pain, and conjunctivitis. Zika has been linked to a severe birth defect called microcephaly which arises in infants of women infected during pregnancy. Microcephaly is marked by an abnormally small head and incomplete brain development. Zika is also associated with Guillain-Barré syndrome, which causes muscle weakness of the limbs and in severe cases may cause almost total paralysis including the inability to breathe. Recent reports suggest Zika may also be linked to other neurological abnormalities and perhaps abnormalities in other body systems.

No vaccine or therapy currently exists for the prevention or treatment of Zika virus infection.